Content

Quality assurance agreements (QAA) define the tasks between manufacturer and supplier, service provider or (triggered by the EU MDR) dealer or importer that must be met with regard to the quality of the products and the certification requirements. In addition, QAAs regulate the obligation to inspect and give notice of defects as part of incoming goods inspection. The agreements have recently been increasingly examined by notified bodies and monitoring authorities and demanded by manufacturers.

The seminar explains what content the QAAs must have and how individual regulations can be designed in order to meet the regulatory requirements on the one hand and avoid liability risks on the other.

Topic overview

  • Legal framework
  • Minimum requirements for QAA
  • Obligation to inspect and give notice of complaints during incoming goods inspection
  • Audit rights
  • Delimitation of the parties' responsibilities with regard to product liability
  • “OEM” and “PLM” as a special supplier relationship – special features under the EU MDR
  • QAA on the sales side
  • Relationship between QAA and framework supply agreements

target group

Managing directors and board members, executives and employees of manufacturers, dealers and importers of medical devices as well as medical technology retailers.

Prior knowledge

Not required.

Early bird discount

If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.

KONTAKT:
Online

 

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